DeviceClearance

Product code OCZ— Gastroenterology, Urology

OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)

Classification name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
74
First cleared
Most recent

FDA classification definition

“To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.”

— U.S. Food and Drug Administration, device classification record for product code OCZ under 21 CFR 876.1500, via openFDA

Market context for product code OCZ

FDA has cleared 74 devices under product code OCZ between 1976 and 2026, filed by 44 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OCZ

Recent clearances under product code OCZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.